Comparative Study Between Wide and Narrow Fenstrum Endoscopic DCR
1 other identifier
interventional
30
1 country
1
Brief Summary
The aim of the study is to compare the efficacy and effectiveness of Endoscopic Endonasal DCR with narrow fenstrum approach and Endoscopic Endonasal DCR with wide fenstrum approach .
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2018
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 18, 2018
CompletedFirst Submitted
Initial submission to the registry
April 1, 2021
CompletedFirst Posted
Study publicly available on registry
April 6, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 18, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
October 18, 2021
CompletedApril 6, 2021
April 1, 2021
2.9 years
April 1, 2021
April 2, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Endoscopic assessment
Measurement dimensions of the DCR ostium by measuring length and width in mile meters by using nasal endoscope
1 year postoperative
Objective assessment
Objective assessment by flourscine disappearance test
1 year postoperative
Study Arms (2)
Wide fenstrum Endoscopic DCR
ACTIVE COMPARATORNarrow Fenstrum Endoscopic DCR
ACTIVE COMPARATORInterventions
Endoscopic DCR
Eligibility Criteria
You may qualify if:
- All patients presented with epiphora due to nasolacrimal duct obstruction with patent canaliculi.
- failed conservative treatment in the form of systemic antibiotics, steroid/antibiotic eye drops, decongestant nasal drops and local nasal steroid spray.
- fit for surgery under general anesthesia.
You may not qualify if:
- Epiphora due to pre-saccal obstruction of lacrimal drainage system.
- \. Eye disease causing increased lacrimation and eyelid malposition
- \. Lacrimal fistula.
- \. Tumors of the lacrimal passage, nose or paranasal sinus.
- \. Patients with abnormal bleeding or coagulation time.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ahmed ragab
Cairo, 002, Egypt
Related Publications (3)
Bertaux PJ, Gan G, Hirtz G, Mouret P, El-Hachem F, Lhuillier L, Perone JM. Evaluation of ostium size following endoscopic dacryocystorhinostomy as a predictive factor of outcome: A prospective study. J Fr Ophtalmol. 2021 Mar;44(3):397-403. doi: 10.1016/j.jfo.2020.05.024. Epub 2020 Dec 30.
PMID: 33388192BACKGROUNDAli MJ, Psaltis AJ, Wormald PJ. Dacryocystorhinostomy ostium: parameters to evaluate and DCR ostium scoring. Clin Ophthalmol. 2014 Dec 9;8:2491-9. doi: 10.2147/OPTH.S73998. eCollection 2014.
PMID: 25525327BACKGROUNDMann BS, Wormald PJ. Endoscopic assessment of the dacryocystorhinostomy ostium after endoscopic surgery. Laryngoscope. 2006 Jul;116(7):1172-4. doi: 10.1097/01.mlg.0000218099.33523.19.
PMID: 16826055BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Investigator
Study Record Dates
First Submitted
April 1, 2021
First Posted
April 6, 2021
Study Start
September 18, 2018
Primary Completion
August 18, 2021
Study Completion
October 18, 2021
Last Updated
April 6, 2021
Record last verified: 2021-04